(Beyond Pesticides, June 6, 2017) Last week, the U .S. Court of Appeals for the Ninth Circuit concluded that the U.S. Environmental Protection Agency (EPA) failed to show that its conditional registration of the antimicrobial, nano-silver pesticide product “NSPW-L30SS” (previously “Nanosilva”) is in the public interest and revoked its registration. The case, brought by the Natural Resources Defense Council (NRDC) and the Center for Food Safety (CFS), challenged the approval of the novel nanotechnology which was marketed for use in an unknown number of textiles and plastics. The decision underscores the need for EPA to ensure pesticide products, including nanomaterials, meet the standards of federal pesticide law.

According to the Center for Food Safety, the Court’s decision is the first of its kind to address EPA’s responsibilities in issuing conditional registrations of new pesticide products like NSPW-L30SS. In its ruling, the Court ruled that EPA had failed to show that “conditional approval” of NSPW-L30SS as a new pesticide supported a public interest finding by the EPA with substantial evidence. EPA had conditionally registered the controversial pesticide back in 2015. Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA can only conditionally register new active ingredients, such nanosilver particles, if EPA determines that the registration is “in the public interest.” In the case of NSPW-L30SS, EPA stated that the registration could “potentially” reduce the amount of silver released into the environment, if all users of conventional silver pesticide products switched to nanosilver and no new users started using nanosilver. The Ninth Circuit rejected these assumptions, holding that merely stating that a pesticide “has the ‘potential’ to be in the public interest” falls short of what the law requires. The Court therefore revoked the conditional registration of the pesticide in whole.

The court decision further warns, “Nanosilver, due to its much smaller particle size, can have significantly different properties than conventional silver. These different properties provide new benefits and opportunities to industry. But with these new benefits come new risks.” Studies find that nanoproducts carry with them significant risks to people and the environment, including DNA damage to plants,increasing bacterial resistance to antimicrobials, and toxic and potentially lethal impacts on fish.

Specifically, the decision states, “The panel held, however, that substantial evidence did not support the EPA’s finding that use of NPSW was in the public interest because it had the “potential” to reduce the amount of silver released into the environment. The panel held that the EPA’s finding was based on two unsubstantiated assumptions: first, that current users of conventional-silver pesticides would replace those pesticides with NSPW; and second, that NSPW would not be incorporated into new products to the extent that such incorporation would actually increase the amount of silver released into the environment. The panel concluded that without evidence in the record to support the assumptions, it could not find that the EPA’s public-interest finding was supported by substantial evidence as required by the Act.”

This case also highlights the deficiencies of the controversial conditional registration process at EPA. EPA’s conditional approval of the nanoproduct exemplifies the agency’s allowance of products into the market without sufficient and legally required data. A 2013 U.S. Government Accountability Office (GAO) report concludes that, “EPA does not have a reliable system to track key information related to conditional registrations, including whether companies have submitted additional data within required timeframes.” This latest court decision shows that products must be fully evaluated before being allowed onto the market, and that continued conditional registration of products is contrary to the EPA’s mission.

Nanotechnology is a platform technology for manipulating materials at the atomic and molecular level; manufactured nanomaterials are so small that they cannot be seen with an ordinary microscope. Yet, “nano” means more than just tiny; it means materials that have the capacity to act in fundamentally novel ways, ways that cannot be predicted from the same materials at larger scale. Their exponentially small size gives them extraordinary mobility for a manufactured material, as well as unique chemical and biological properties. Nanomaterials’ properties increase potential for biological interaction and increase potential for toxicity. Nano-silver products are overwhelmingly the most common nanomaterial in consumer products, commonly used as a powerful antimicrobial agent.

In 2008, a coalition of more than 13 organizations, including Beyond Pesticides, filed a legal petition requesting, among other things, that EPA recognize the risks associated with a growing class of nanosilver consumer products and regulate them as new pesticides. In December 2014, some of the petitioner groups sued the agency to force it to respond, and in 2015, EPA agreed to regulate novel nanomaterial pesticides as a result of the lawsuit. In the 2008 petition, petitioners identified 260 nanosilver consumer products not registered under FIFRA. That number has increased to over 400 nanosilver products on the market today. Because there are no labeling requirements for nano-scale products, many more likely exist. Nanomaterials can be incorporated into any consumer product, except those approved for food-contact uses. They are in toys, clothing, yoga mats, shoes, kitchen appliances and housewares, building materials, HVACs, bathroom fixtures and accessories, combs, brushes, offices supplies and many more.